On the eve of today's scheduled cabinet vote on the data exclusivity law for drug registration files, the US notified Israel that it rejected the proposed bill, and demanded a number of substantial changes in it.
Minister of Industry Trade and Labor Ehud Olmert confirmed that the cabinet would not vote on the recommended revisions in the law. Generic drug makers, headed by Teva Pharmaceuticals (Nasdaq: TEVA; TASE:TEVA), also urged that the changes be rejected, but it was apparently the US rejection that led to the postponement.
Ministry of Industry director general Raanan Dinur told "Globes", "In weighing various interests, it was always clear that the changes might cause Teva and other companies to move their activities overseas, but the exchange would have been an anticipated increase in the business of international pharmaceutical companies."
Negotiations with the US Trade Representative (USTR) are expected to continue in the coming days, in a last-minute effort to avoid Israel's inclusion in the USTR's updated priority watch list of countries that violate intellectual property rights, due on May 1.
Drug registration files are not protected under current Israeli law. International pharmaceutical companies, especially US companies, oppose some of the bill's provisions, and are applying heavy pressure on Israel through the Bush administration and US Ambassador to Israel Dan Kurtzer.
The international pharmaceutical companies oppose recommendations granting only marketing exclusivity, demanding data exclusivity for drug registration files instead. The data exclusivity period is five years in the US and ten years in the EU.
Data exclusivity covers cases in which a drug has no patent Israel, or the patent has expired. The international pharmaceutical companies are demanding that the Ministry of Health be banned from providing Israeli generic drug makers, headed by Teva, with information about clinical trials found in the ethical drug registration files submitted to the ministry.
In contrast, marketing exclusivity means that a generic company can develop and register a generic drug during the data exclusivity period, but cannot market it until the data exclusivity period has expired.
The interministerial committee for protecting intellectual property rights for pharmaceuticals acceded to another US demand against Israel's generic drug makers, which wanted the exclusivity period to begin from the date an ethical drug is registered in Israel.
Published by Globes [online] - www.globes.co.il - on April 25, 2004